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Class II · ModerateActive recall

Lidocaine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySpectra Medical Devices, LLC
Brand nameLIDOCAINE HYDROCHLORIDE
Generic nameLIDOCAINE HYDROCHLORIDE ANHYDROUS
Active ingredient(s)LIDOCAINE HYDROCHLORIDE ANHYDROUS
Distributed by / forSpectra Medical Devices, LLC, Wilmington
NDC65282-1605-1
Show the full FDA record
Full product labelLidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Recalling firmSpectra Medical Devices, Llc
DistributionUSA Nationwide
Quantity210625 ampules
Recall initiated2026-05-12
Report date2026-06-10
Recall completed—
Recall numberD-0554-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWilmington MA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.